Automated implantable penile prosthesis pump system

ABSTRACT

A dual poppet valve assembly for a pump assembly of an implantable penile prosthesis having a suction poppet engagable by a plurality of fingers allowing free travel of the poppet and to prevent vacuum lockup of the pump assembly. The suction poppet can also include an elongated shaft receivable within a corresponding bore of a cylinder poppet to prevent the suction poppet from becoming misaligned during the operation of the pump assembly.

RELATED APPLICATION

The present application claims the benefit of U.S. ProvisionalApplication No. 61/613,770 filed Mar. 21, 2012, and entitled “AUTOMATEDIMPLANTABLE PENILE PROSTHESIS PUMP SYSTEM”, which is incorporated hereinin its entirety by reference.

FIELD OF THE INVENTION

The present invention is generally directed to a pump system for animplantable penile prosthesis. Specifically, the present invention isdirected to a suction poppet assembly for an implantable penileprosthesis pump system.

BACKGROUND OF THE INVENTION

Implantation of an implantable penile prosthesis (IPP) is a commonsurgical procedure for treating erectile dysfunction and other penileailments. An IPP comprises an inflatable cylinder connected by a pump toa separate reservoir for holding the quantity of fill liquid via kinkresistant tubing. This version of the IPP is available under the tradename AMBICOR from American Medical Systems of Minnetonka, Minn.Typically, the entire IPP is implanted into the patient's body with theinflatable cylinder being placed in the corpus cavernosum and the pumpbeing placed within the scrotum. The reservoir can also be placed withinthe scrotum or placed elsewhere within the pelvic region. To operate theIPP, the pump is manually actuated to transfer fill liquid from theintegrated or implanted reservoir into the inflatable cylinder to filland pressurize the inflatable cylinder.

A typical pump system for an IPP comprises a pump bulb that can becompressed to draw fluid from a reservoir and push the inflation fluidinto the inflatable cylinder. Generally, the pump is compressed andreleased to draw fluid from the reservoir into the pump. The pump iscompressed again to force fluid from the pump into the inflatablecylinder. Two selective poppet valves are positioned along the flow pathbetween reservoir and inflatable cylinder to control the direction ofthe fluid flow through the pump system.

Typically, the IPP and the pump system are provided to the medicalpersonnel without any working fluid within the system. Prior toimplantation, each component of the IPP is filled or nearly filed withthe working fluid by the medical personnel. The medical personnel alsooften test the operation of the IPP to insure that the all thecomponents of the IPP are functioning properly prior to implantation.However, if too much air remains in the IPP when the pump system isoperated by the medical personnel or the patient, the air within thesystem can cause pump to lock up. Specifically, the pump bulb can remaincompressed after being actuated rather than re-expanding to drawadditional fluid into the pump bulb.

Another drawback of the pump system is that the poppet valves can becomemisaligned during filling and operation of the IPP and pump system. Ifthe poppet becomes misaligned, uncontrolled leakage can occur allowingfluid to travel through the fluid pathway. Similarly, the misalignedpoppet can become stuck preventing any operation of the poppet.

As such, there is a need for a pump system for an IPP that can beoperated by medical personnel with a reduced risk of damage ormalfunction during test operation.

SUMMARY OF THE INVENTION

The present invention is directed to an IPP having a valve assemblycomprising a dual poppet design. The valve assembly is integrated into apump assembly comprising a pump bulb that can be actuated to transferworking fluid from a reservoir to at least one inflatable cylinder. Thevalve assembly defines a valve flow path, for example, a generallylinear flow path, between the reservoir and the inflatable cylinder. Thevalve flow path intersects the opening to the pump bulb such thatactuating the pump bulb moves fluid along the flow path. In one aspect,the valve flow path also defines a suction annulus positioned in thevalve flow path between the reservoir and the pump bulb. Similarly, thevalve flow path can also define a cylinder annulus positioned betweenthe pump bulb and the cylinder.

In one aspect, the valve assembly comprises a suction poppet engagableto the suction annulus and a cylinder poppet engagable to the cylinderannulus. Each poppet is movable along a central axis defined by the flowpath between an engaged position in which the poppet is engaged to itscorresponding annulus to prevent the flow of working fluid through theannulus and a disengaged positioned wherein the poppet is positioned toallow working fluid to pass through the corresponding annulus. In oneaspect, the poppets are both biased to the engaged position to preventflow of working fluid until the pump bulb is actuated. The suctionpoppet is positioned on the pump bulb side of the suction annulus suchthat releasing the compressed pump bulb creates a suction that pulls thesuction poppet into the disengaged position and draws a quantity ofworking fluid through the suction annulus into the pump bulb. Incontrast, the cylinder poppet is positioned on the opposite side of thecylinder annulus from the pump bulb, wherein compressing the pump bulbcreates a positive pressure pushing the cylinder poppet into thedisengaged position and a forcing a quantity of working fluid throughthe cylinder annulus into the inflatable cylinder.

In one aspect, the flow path further defines an annular ring positionedbetween the suction annulus and the pump bulb opening. If the pump bulbis actuated too quickly and/or air is present within the pump bulbopening such as, for example, during the initial installation, thesuction poppet can become wedged against the annular ring blocking allflow and creating a vacuum condition essentially locking the pump bulbin the compressed state. In one aspect, the suction poppet can furthercomprise a head extending through the suction annulus. The head candefine a lip engagable by a plurality of fingers extending from thesuction annulus. The fingers engage the lip when the suction poppet isslid into the disengaged position to prevent the suction poppet fromengaging the annular ring and creating vacuum lock up. The fingers allowfor a controlled travel distance of the suction poppet preventing vacuumlock up of the pump bulb.

In one aspect, the suction puppet can further comprise an elongatedsuction poppet shaft extending through the cylinder annulus. In thisconfiguration, a cylinder poppet can define defines a cylinder poppetbore for slidably receiving the elongated suction poppet shaft. If thesuction poppet becomes misaligned, the suction poppet may not properlyengage the suction annulus allowing working fluid to leak through thesuction annulus. The cylinder poppet bore guides the suction poppet tomaintain an axial alignment of the suction poppet along a valve chamberaxis as the suction poppet moves between the engaged position and thedisengaged position relative to suction annulus.

In one aspect, the valve assembly can further comprise a release buttonthat can be pressed against an elongated head of the suction poppet topush the suction poppet to the disengaged position along the valvechamber axis without operating the pump bulb. The elongated suctionpoppet shaft can be used to push against an end of the cylinder poppetbore such that both the suction poppet and the cylinder poppet arepositioned in the disengaged position allowing free flow through thevalve flow path. The release button can be used to return the workingfluid to the reservoir from the inflatable cylinder. The release buttoncan also be used to reset the operation of the valve assembly.

A method of preventing vacuum lock up of the pump bulb, according to anaspect of the present invention, can comprise providing a suction poppetpositioned between the suction annulus leading to the reservoir and thepump bulb, wherein the suction poppet further comprises an elongatedhead extending through the suction annulus. The method can furthercomprise defining a plurality of fingers extending from the suctionannulus to limit the travel distance of the suction poppet and preventuncontrolled engagement of the suction poppet to other features withinthe valve assembly.

The above summary of the various representative embodiments of theinvention is not intended to describe each illustrated embodiment orevery implementation of the invention. Rather, the embodiments arechosen and described so that others skilled in the art can appreciateand understand the principles and practices of the invention. Thefigures in the detailed description that follow more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention can be completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is a top view of a implantable penile prosthesis according to anembodiment of the present invention.

FIG. 2 is a partial cross-sectional view of a valve assembly accordingto an embodiment of the present invention.

FIG. 3 is a side view of a suction poppet according to an embodiment ofthe present invention.

FIG. 4 is a perspective view of a suction annulus with a head of thesuction poppet extending through annulus according to an embodiment ofthe present invention.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION

As shown in FIG. 1, an implantable penile prosthesis (IPP) 2, accordingto an embodiment of the present invention, comprises at least oneinflatable cylinder 4, a reservoir 6, a pump 8 and a valve assembly 10.The pump 8 can further comprise a pump bulb 12 that can be compressedand released to draw and pump working fluid. The IPP 2 generallyoperates by actuating the pump bulb 12 to draw a quantity of workingfluid from the reservoir 6 and pumping the working fluid into theinflatable cylinder 4. The valve assembly 10 is generally adapted toprevent back flow of the working fluid during operation of the pump 8 toinflate inflatable cylinder 4.

As shown in FIGS. 1-2, the valve assembly 10 defines a valve flow path14 and comprises a suction poppet 16 and a cylinder poppet 18. The valveflow path 14 is defined between a reservoir inlet 20 from the reservoir6 and a cylinder outlet 22 leading to the cylinder 4. The valve flowpath 14 also further comprises a linear valve chamber 24 extending alonga central valve chamber axis a-a. The linear valve chamber 24 defines apump bulb opening 26 providing fluid communication between the pump bulb12 and the linear valve chamber 24. The linear valve chamber 24 alsodefines a suction annulus 28 and an annular ring 30 positioned betweenthe reservoir inlet 20 and the pump bulb opening 26. Similarly, thelinear valve chamber 24 also defines a cylinder annulus 32 positionedbetween the pump bulb opening 26 and the cylinder outlet 32. In oneaspect, the suction annulus 28 further comprises a plurality of fingers34 as shown in FIG. 4 that extend radially toward the central valvechamber axis a-a.

As shown in FIGS. 2-3, the suction poppet 16 defines a sealing surface36 and is linearly movable along the central valve chamber axis a-abetween an engaged position and a disengaged positioned. In the engagedposition, the sealing surface 36 is engaged to the suction annulus 28preventing flow of working fluid through the suction annulus 28. In thedisengaged positioned, the sealing surface 36 is disengaged from thesuction annulus 28 allowing working fluid to pass through the suctionannulus 28. As shown in FIGS. 2-3, the suction poppet 16 is positionedon the pump bulb opening 26 side of the suction annulus 28 such that thesuction poppet 16 is biased to maintain flow in a single directionduring inflation of the cylinders 4. In one aspect, the suction poppet16 further comprises a suction poppet spring 38 maintaining the suctionpoppet 16 in the engaged position to prevent flow through the valve flowpath 14 without operation of the pump bulb 12.

In one aspect, the suction poppet 16 further comprises an elongated head40 extending through the suction annulus 28 and defining a lip 42engagable by the plurality of fingers 34 when the suction poppet 16moves toward the disengaged position limiting the travel distance of thesuction poppet 16 and preventing the suction poppet 16 from engaging theannular ring 30.

As shown in FIG. 2, the cylinder poppet 18 also defines a sealingsurface 44 engagable to the cylinder annulus 32. The cylinder poppet 18is also movable along the central valve chamber axis a-a between anengaged position in which the sealing surface 44 is engaged to thecylinder annulus 32 preventing flow of working fluid through thecylinder annulus 32 and a disengaged positioned allowing working fluidto pass through the annulus 32. As shown in FIG. 2, the cylinder poppet18 is positioned on the cylinder outlet 22 side of the cylinder annulus32 such that the cylinder poppet 18 is biased to maintain a flowdirection from the reservoir 6 to the cylinder 4 during normaloperation. In one aspect, the cylinder poppet 18 further comprises acylinder poppet spring 45 to maintain the suction poppet 16 in theengaged position to prevent flow through the valve flow path 14 withoutoperation of the pump bulb 12.

In one aspect, the cylinder poppet 18 further comprises an elongatedcylinder poppet shaft 46 and defines a lip 48. In this configuration,the valve flow path 14 further defines a cylinder journal 50 defining ajournal bore 52 for receiving the elongated cylinder poppet shaft 46.The journal bore 52 guides the cylinder poppet 18 along the centralvalve chamber axis a-a during movement of the cylinder poppet 18 betweenthe engaged and disengaged position such that the cylinder poppet 18 isprevented from moving along an axis transverse to the central valvechamber axis a-a. The cylinder journal 50 also engages the lip 48 of thecylinder poppet 18 when the poppet 18 moves to the disengaged positionto limit the travel of the cylinder poppet 18.

In one aspect, the suction poppet 16 can further comprise an elongatedsuction poppet shaft 54 extending through the cylinder annulus 32. Inthis configuration the cylinder poppet 18 further defines a cylinderpoppet bore 56 for receiving the elongated suction poppet shaft 54. Thecylinder poppet bore 56 guides the elongated suction poppet shaft 54along the central valve chamber axis a-a during movement of the suctionpoppet 16 between the engaged and disengaged position such that thesuction poppet 16 is prevented from moving along an axis transverse tothe central valve chamber axis a-a. The elongated suction poppet shaft54 can also be used to engage the end of the cylinder poppet bore 56 topush the cylinder poppet 18 into the disengaged position.

In operation, compressing the pump bulb 12 creates a positive pressurepushing working fluid and/or air within the pump bulb 12 out of the pumpbulb opening 26 into the valve flow path 14. The positive pressure alsopushes against the cylinder poppet 18 moving the cylinder poppet 18 intothe disengaged position forcing the fluid and/or air into the inflatablecylinder 4. Releasing the compressed pump bulb 12 allows the pump bulb12 to expand and creates a vacuum pulling the cylinder poppet 18 intothe engaged position and the suction poppet 16 into the disengagedposition allowing working fluid to be drawn from the reservoir 6 intothe pump bulb 12. The process can be repeated to continuously drawworking fluid from the reservoir 6 to inflate the inflatable cylinder 4.

In one aspect, the valve assembly 10 can further comprise a releasebutton 58 for allowing fluid to flow in reverse through the valve flowpath 14. The release button 58 can be actuated to push against theelongated head 40 to push the suction poppet 16 into the disengagedposition. In this configuration, the elongated suction poppet shaft 54is adapted to engage the end of the cylinder poppet bore 56 to push thecylinder poppet 18 into the disengaged position. With both the suctionpoppet 16 and the cylinder poppet 18 are in the disengaged position withrespect to the their corresponding annulus, the pressure of the workingfluid within the inflatable cylinder 4 pushes working fluid through thevalve flow path 14 back to the reservoir 6.

As shown in FIG. 2, a method of preventing vacuum lock up of the pumpbulb 12 comprises positioning the suction poppet 16 positioned betweenthe suction annulus 28 and the pump bulb 12, wherein the suction poppet16 further comprises an elongated head 40 extending through the suctionannulus 28. The method further comprises defining a plurality of fingers34 extending from the suction annulus 28 to limit the travel distance ofthe suction poppet 16 to prevent uncontrolled engagement of the suctionpoppet 16 to other features within the valve assembly 10.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and described in detail. It is understood, however, that theintention is not to limit the invention to the particular embodimentsdescribed. On the contrary, the intention is to cover all modifications,equivalents, and alternatives falling within the spirit and scope of theinvention as defined by the appended claims.

1. A valve assembly for an implantable penile prosthesis, comprising: avalve flow path defined between a reservoir inlet and a cylinder outlet,the valve flow path being fluidly connected to pump bulb opening, thevalve flow path extending linearly along a valve chamber axis with asuction poppet and a cylinder poppet positioned within the valve flowpath and being movable along the valve chamber axis, the cylinder poppetincluding an extended cylinder shaft that is slidably received within acylinder journal integral to the valve flow patch, wherein theinteraction of the cylinder journal and extended cylinder shaft retainaxial alignment of the cylinder poppet along the valve chamber axis asthe cylinder poppet transitions between an engaged position and adisengaged position.
 2. The valve assembly of claim 1, wherein thecylinder poppet includes a cylinder poppet bore and the suction poppetincludes an elongated suction poppet shaft, the elongated suction poppetshaft being slidably received within the cylinder poppet bore to retainaxial alignment of the suction poppet along the valve chamber axis. 3.The valve assembly of claim 1, further comprising a tapered cylinderpoppet spring, wherein the tapered cylinder poppet spring is positionedover the extended cylinder shaft and the cylinder journal, and whereinthe cylinder journal retains axial alignments of the tapered cylinderpoppet spring along the valve chamber axis.
 4. The valve assembly ofclaim 1, wherein the valve flow path defines a suction annulus includinga plurality of protruding fingers, the suction poppet positioned throughthe suction annulus such that the plurality of protruding fingers retainthe suction poppet along the valve chamber axis.
 5. The valve assemblyof claim 4, wherein the valve chamber axis is perpendicular to thesuction annulus.
 6. The valve assembly of claim 1, further comprising arelease button, said release button being actuatable along the valvechamber axis such that the release button contacts an elongated head ofthe suction poppet so as to slidably direct the suction poppet along thevalve chamber axis.
 7. A valve assembly for an implantable penileprosthesis, comprising: a valve flow path defined between a reservoirinlet and a cylinder outlet, the valve flow path being fluidly connectedto pump bulb opening, the valve flow path extending linearly along avalve chamber axis with a suction poppet and a cylinder poppetpositioned within the valve flow path and being movable along the valvechamber axis, wherein the valve flow path defines a suction annulusincluding a plurality of protruding fingers, the suction poppetpositioned through the suction annulus such that the plurality ofprotruding fingers retain the suction poppet along the valve chamberaxis.
 8. The valve assembly of claim 7, wherein the cylinder poppetincludes an extended cylinder shaft that is slidably received within acylinder journal integral to the valve flow path, wherein theinteraction of the cylinder journal and extended cylinder shaft retainaxial alignment of the cylinder poppet along the valve chamber axis asthe cylinder poppet transitions between an engaged position and adisengaged position.
 9. The valve assembly of claim 8, furthercomprising a tapered cylinder poppet spring, wherein the taperedcylinder poppet spring is positioned over the extended cylinder shaftand the cylinder journal, and wherein the cylinder journal retains axialalignments of the tapered cylinder poppet spring along the valve chamberaxis.
 10. The valve assembly of claim 7, wherein the valve chamber axisis perpendicular to the suction annulus.
 11. The valve assembly of claim7, further comprising a release button, said release button beingactuatable along the valve chamber axis such that the release buttoncontacts an elongated head of the suction poppet so as to slidablydirect the suction poppet along the valve chamber axis.
 12. A valveassembly for an implantable penile prosthesis, comprising: a valve flowpath defined between a reservoir inlet and a cylinder outlet, the valveflow path being fluidly connected to pump bulb opening, the valve flowpath extending linearly along a valve chamber axis with a suction poppetand a cylinder poppet positioned within the valve flow path and beingmovable along the valve chamber axis, wherein the suction poppet isactuatable with a release button, the release button contacting anelongated head on the suction popped to direct the suction poppet alongthe valve chamber axis.
 13. The valve assembly of claim 12, wherein thevalve flow path defines a suction annulus including a plurality ofprotruding fingers, the elongated head positioned through the suctionannulus such that the plurality of protruding fingers retain the suctionpoppet along the valve chamber axis.
 14. The valve assembly of claim 13,wherein the valve chamber axis is perpendicular to the suction annulus.15. The valve assembly of claim 12, wherein the cylinder poppet includesan extended cylinder shaft that is slidably received within a cylinderjournal integral to the valve flow path, wherein the interaction of thecylinder journal and extended cylinder shaft retain axial alignment ofthe cylinder poppet along the valve chamber axis as the cylinder poppettransitions between an engaged position and a disengaged position. 16.The valve assembly of claim 15, further comprising a tapered cylinderpoppet spring, wherein the tapered cylinder poppet spring is positionedover the extended cylinder shaft and the cylinder journal, and whereinthe cylinder journal retains axial alignments of the tapered cylinderpoppet spring along the valve chamber axis.
 17. The valve assembly ofclaim 15, wherein the cylinder poppet includes a cylinder poppet boreand the suction poppet includes an elongated suction poppet shaft, theelongated suction poppet shaft being slidably received within thecylinder poppet bore to retain axial alignment of the suction poppetalong the valve chamber axis.